Pertussis, Whooping cough Pertussis, Whooping cough
Conditions
Interventions
Tetanus toxoid,
reduced diphtheria toxoid and recombinant acellular pertussis vaccine ,Diphtheria toxoid,
tetanus toxoid and recombinant acellular pertussis vaccine ,Diphtheria toxoid,
tetanus toxoid and acellular pertussis vaccine and Inactivated Polio Vaccine (IPV)
BIoNet Recombinant TdaP ,BioNet Recombinant DTaP , licensed DTaP-
Sponsors
BioNet-Asia Co., Ltd.
Eligibility
Sex/Gender
All
Age
3 Years to 7 Years
Inclusion criteria
Inclusion criteria: Participants will be eligible for inclusion if ALL of the following criteria are met at the time of screening: 1. 3 to 7 years of age (less than 8 years full of age); 2. Having completed the 4-dose DTwP vaccination according to Thai EPI; 3. Able to provide written informed assent and parents or legal guardians of the participant can provide written informed consent; 4. Healthy, as established by pertinent medical history and physical examination; 5. Capable of complying with the study protocol within the investigator's judgment. 6. Parents or legal guardians must be able to read and write in Thai.
Exclusion criteria
Exclusion criteria: A participant with ANY of the following criteria at study entry will not be eligible for participation: 1. History of any significant medical illness such as, but not limited to, immune deficiency, renal, hepatic, cardiovascular, or endocrine disorder as determined by the investigator based on medical history and physical examination; 2. History of allergy or hypersensitivity to any vaccine (including its component); 3. History of any serious adverse event or neurological adverse event after vaccination; 4. Having received diphtheria or tetanus or pertussis vaccine within 1 year prior to recruitment; 5. Having experienced a physician diagnosed diphtheria or tetanus or pertussis illness within 1 year prior to recruitment; 6. Receipt of any vaccine within 28 days prior to enrollment (3 months for live-attenuated vaccines); 7. Planning to receive tetanus, diphtheria or pertussis vaccines or planning to participate in another clinical trial during the study period (approximately 6 months); 8. Receipt of blood or blood component or immunoglobulin within 3 months prior to recruitment; 9. History of receiving any immunosuppressive drug or systemic corticosteroid (more than 0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to recruitment; 10. Any bleeding disorder; 11. Any abnormality of splenic or thymic function; 12. Any progressive or severe neurological disorder such as seizure disorder or Guillain-Barr syndrome; 13. History of any illness including cognitive impairment and psychiatric disease that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; 14. Fever as defined by body temperature more than 38 degree celsius at the time of enrollment (temporary exclusion criterion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of recombinant TdaP and recombinant DTaP At day 28 after vaccination Information from Dairy Card and safety assessment by investigator,Safety of recombinant TdaP and recombinant DTaP At day 28 after vaccination Information from Dairy Card and safety assessment by investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of recombinant TdaP and recombinant DTaP for 6 months Within 6 months after vaccination Assessment from Dairy Card and Medical Examination by investigator,Immunogenicity of one dose of recombinant TdaP&recombinant DTaP vaccine compared to licensedDTaP-IPV At day 28 after vaccination ELISA anti-PT and anti-FHA antibodies,Immunogenicity of one dose of recombinant TdaP&recombinant DTaP vaccine compared to licensedDTaP-IPV At day 28 after vaccination PT-neutralizing antibodies' levels | — |
Countries
Thailand
Contacts
Public ContactSouad Mansouri
Bionet-Asia Co., Ltd.
Outcome results
None listed